Advanced Therapies for Liver Metastases

Launched by IRCCS SAN RAFFAELE · Nov 4, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating new treatments for patients with liver metastases, which occur when cancers like colorectal cancer (CRC) and pancreatic ductal adenocarcinoma (PDAC) spread to the liver. The researchers believe that advanced therapies, including immune, gene, and cell therapies, may help the body’s immune system fight these cancers more effectively. They will enroll different groups of patients with CRC and PDAC to study their tumors and the environment around them, aiming to find new ways to diagnose and treat these conditions.

To participate in the trial, you need to be at least 18 years old and have a confirmed diagnosis of stage IV CRC or PDAC that has spread to the liver. Patients will undergo various tests, and the goal is to gather information that could lead to new treatment options in the future. The trial is currently recruiting participants, and those who join will be closely monitored over time to help identify the best ways to tailor treatments for individuals. This study is important because it could pave the way for better therapies for these challenging cancers.

Gender

ALL

Eligibility criteria

• • Inclusion and exclusion criteria - CRC patients
• Inclusion criteria:
• • 1. Patients with histologically or cytologically confirmed diagnosis of CRC metastatic to the liver (stage IV disease, AJCC)
• • 2. Patients with indication to surgical resection and/or chemotherapy treatment
• • 3. Age ≥18
• • 4. ECOG PS 0-1 at enrollment
• • 5. Written informed consent
• • 6. Patients will be treated in IRCCS San Raffaele
• Exclusion criteria:
• • 1. Pregnancy or lactation
• • 2. Inability to provide a written informed consent
• • 3. Extraepatic disease with the exception of selected cases in which the coexistence of extrahepatic disease does not constitute an exclusion criterion for hepatic resective surgery (for example in patients with extraepatic lesions in remission or in any case stabilized by chemotherapy)
• • 4. Severe comorbidities (e.g. cardiac diseases, history of psychiatric disabilities, HIV, autoimmune disorders)
• • 5. Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy
• • 6. Other conditions (medical or psychiatric) that in the judgment of Investigators would make the patient an inappropriate candidate for the study
• • Inclusion and exclusion criteria - PDAC patients
• Inclusion criteria:
• • 1. Patients with clinical/radiological diagnosis/suspicious of pancreatic adenocarcinoma metastatic to the liver, with subsequent cytological/histological confirmation (stage IV disease, AJCC)
• • 2. Age ≥18
• • 3. Karnofsky performance status ≥50
• • 4. Metastatic pancreatic adenocarcinoma patients with histological specimens from whole liver metastasis biopsy or core liver biopsy collected at IRCCS San Raffaele and stored in the institutional biobank Centro Risorse Biologiche (CRB-OSR)
• • 5. Written Informed consent
• • 6. Patients with clinical/radiological diagnosis of not metastatic primary PDAC that will undergo pancreatic resection at IRCCS San Raffaele
• Exclusion criteria:
• • 1. Severe comorbidities (e.g., cardiac diseases, history of psychiatric disabilities) representing an absolute contraindication for whole or core liver metastasis biopsy
• • 2. Pregnancy or lactation
• • 3. Inability to provide a written informed consent
• • 4. Metastatic pancreatic adenocarcinoma patients enrolled in other research trials entailing the analysis of the liver metastasis histological sample